Method of storing and retrieving products using cryogenic storage rack with rotatable shelves

ABSTRACT

A storage rack for storing and retrieving products to be maintained at a desired cryogenic temperature is provided. The storage rack includes an elongate mounting bar carrying a plurality of shelves, and an elongate stop bar that extends generally parallel to the mounting bar. The shelves are independently rotatable relative to the mounting bar towards and away from the stop bar, thereby enabling alignment of all of the shelves when the storage rack is to be stored, and also enabling easy access to each of the individual shelves. A handle projects upwardly and horizontally in a curved configuration from the stop bar and the mounting bar to provide a gripping surface for moving the storage rack. The shelves receive cylindrical vial containers with threadably removable lids to make retrieval and replacement of sample vials quick to perform, thereby avoiding temperature-induced damage to other samples in the storage rack.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of, and claims priority to,U.S. patent application Ser. No. 15/484,662, filed Apr. 11, 2017, theentire disclosure of which is incorporated by reference herein.

TECHNICAL FIELD

The present invention relates generally to refrigerated storage systemsand, more particularly, to storage racks configured to receive drugsamples and/or biological samples for transport and cryogenic storage.

BACKGROUND

Biological and drug samples are often stored and/or transported forlengthy periods of time before use. To maintain the viability of suchsamples, the storage or transport units are typically configured withrefrigeration systems or coolants that maintain an interior storagespace at a desired temperature, typically a low or cryogenic temperaturesuch as within a range of about −195° C. to about −40° C. The specifictemperature depends on the samples being stored. In one example, stemcells to be used for research tests and activities are typically storedat about −195° C. to maintain the viability thereof. Allogeneic andautologous drug products may also be stored at similar temperatures, forexample. As will be readily understood, any prolonged exposure of suchsamples to higher temperatures such as room temperatures can causetemperature-induced degradation that may ruin the samples. Therefore, itis important to store and handle these biological and drug samples insuch a manner to avoid those temperature-induced degradations.

Storage of samples in cryogenic containers is typically done with one ormore storage racks that hold and organize a plurality of samples. Oneconventional example of such a storage rack 300 is shown in FIG. 1. Thestorage rack 300 defines a rectangular box shape or cross section formedby a plurality of elongated side walls 302 and an open front surface,with a plurality of shelves 304 provided along the length of the sidewalls 302. The remainder of the rectangular box shape is generallysolid, although there may be air flow apertures formed along the sidewalls 302 as well, to promote cold air flow through the storage spacesdefined at the shelves 304. The storage spaces are sized to receive oneor more sample storage boxes 306, which also define a generallyrectangular cross section. The storage rack 300 of the conventionaldesign further includes a small clip 308 along a top wall 310 whichserves as a handle for moving the storage rack 300, and a retainer bar312 that extends through apertures formed in the top wall 310 and ineach of the plurality of shelves 304 along the open front surface toblock the storage boxes 306 from falling out of the storage spaces. Thestorage rack 300 is typically received in a cylindrical storage sleeve314 during storage in a cryogenic container, these elements being shownseparated from one another in FIG. 1.

Although the storage rack 300 of the conventional design functions toorganize and retain a number of product samples, the use and retrievalof product samples from the storage rack 300 often requires significantprevious experience in order to perform these operations quickly. Tothis end, accessing one of the storage boxes 306 and the productsample(s) therein is a multi-step, relatively complicated process. Morespecifically, the storage rack 300 must first be pulled out of thestorage sleeve 314, and this requires interaction with the small clip308 that serves as a handle for the storage rack 300. It can be highlydifficult to maintain a good grip on this clip 308 when moving thestorage rack 300, as a result of its small size and low profile relativeto the top wall 310. Next, a user must withdraw the retainer bar 312 bypulling it upwardly out of all of the apertures provided in the shelves304 and the top wall 310. Only then can the storage box 306 be removedby the user for accessing one or more of the samples therein. The usermust then return the retainer bar 312 into the inserted position andmanipulate the storage rack 300 using the small clip 308 to re-insertthe storage rack 300 back into the storage sleeve 314 for movement backinto the cryogenic container. As can be readily understood from thisdescription, this multi-step process can take a significant amount oftime, particularly for users without significant experience withretrieving samples from these types of storage racks.

Moreover, the conventional design of the sample storage boxes 306 alsopresents some additional difficulties for users. In this regard, thestorage boxes 306 are typically made from a plastic-like orcardboard-like material with openable lids and box ears, but theseportions of the storage boxes 306 have a tendency to become brittle andsnap off during opening or closing of the storage boxes 306, especiallyafter storage in the cryogenic container at the desired temperature.This problem can negatively impact the reuse of the storage boxes 306,which is typically preferable in many fields. Furthermore, the openingand closing of the storage boxes 306 takes additional time, which canlead to the problems above with prolonged exposure of other samples tohigher temperatures before the storage rack 300 can be replaced into thecryogenic container or environment.

For some types of biological and drug samples, thermal-induceddegradation can begin after as little as 30 seconds of exposure to roomtemperatures outside the cryogenic container. Therefore, the significantamount of time needed to retrieve samples and storage boxes 306 from thestorage rack 300 and then re-assemble and return the storage rack 300 tocryogenic storage presents a risk that the other samples will bedegraded or damaged. Consequently, the conventional designs of storageracks present difficulties for users who need to store and retrieve aplurality of samples in an efficient storage space. While suchdisadvantages can be avoided by users with significant experience inretrieving the storage racks, it is not always possible to have userswith significant experience, which can potentially lead to sampledegradation and loss.

It is desirable, therefore, for further improvements in the cryogenicstorage rack field and associated systems and methods for cryogenicsample storage, which address these and other deficiencies of knowndesigns.

SUMMARY

According to one embodiment of the present invention, a storage rack isprovided for retaining products in a cryogenic environment. The storagerack includes a framework having an elongate mounting bar and anelongate stop bar coupled to one another. The stop bar is spaced apartfrom and extends generally parallel to the mounting bar. A handle iscoupled to at least one of the stop bar and the mounting bar, with thehandle being configured to enable movement of the storage rack as awhole. The storage rack also includes a plurality of shelves pivotallycoupled to the mounting bar so as to be individually and independentlyrotatable relative to an axis through the mounting bar towards and awayfrom contact with the stop bar. Each of the plurality of shelvesincludes a bottom wall and a side wall collectively defining a containerreceptacle. When all of the plurality of shelves are rotated intocontact with the stop bar, the plurality of shelves is aligned with oneanother for storage, such as within a cryogenic container such as aliquid nitrogen (LN2) storage canister. The handle and the individuallyrotatable shelves enable faster access to vial containers and samplescontained on the storage rack because the storage rack can bemanipulated or moved with one hand of a user while the other handrotates a shelf out of alignment with the other shelves and thenretrieves and/or replaces the vial container.

In one aspect, each of the plurality of shelves is configured to berotated away from the stop bar and out of alignment with the othershelves to provide access into the container receptacle defined withinthe rotated shelf. To this end, the shelves can be rotated andreconfigured to a wide variety of positions relative to the framework ofthe storage rack. In another aspect, the side wall of each of theplurality of shelves defines a generally cylindrical shape, therebymaking the container receptacles configured to receive a cylindricalvial container holding one of the products. In such embodiments, theside wall of the shelves may further include a top end positionedopposite the bottom wall, and at least one cutout extending downwardlytowards the bottom wall provided at the top end. For example, opposingcutouts at opposite sides of the top end enables a user to grasp andlift a vial container out of the container receptacle. As with therotation of the shelf, this retrieval step for the vial container can bedone with a single hand in a time efficient manner.

The handle of the storage rack in some embodiments is coupled to both ofthe stop bar and the mounting bar. Accordingly, the handle extendsbetween these elements of the framework to provide an enlarged grippingarea for moving and manipulating the storage rack, preferably with onehand as described above. The handle advantageously projects horizontallyand upwardly from top ends of the stop bar and the mounting bar toproject over a portion of the plurality of shelves. More specifically,the handle defines a curved configuration to define the gripping area atthe portion that projects from the top ends of the stop bar and themounting bar. The large gripping area makes the storage rack easier toretrieve and control when moving the storage rack to and from acryogenic storage.

In yet another aspect, the side wall of each of the shelves furtherincludes a top end positioned opposite the bottom wall, and the storagerack further includes a lid element fixedly coupled to the stop bar. Thelid element is located at a position adjacent the top end of anuppermost shelf when that uppermost shelf is rotated into contact withthe stop bar. To this end, the lid element closes off or covers the topend of the container receptacle defined within the uppermost shelf whenin the aligned configuration for storage. The bottom wall of each of theplurality of shelves also serves as a lid element for an adjacent shelfpositioned immediately beneath the bottom wall, in a similar manner asthe lid element at the top end of the uppermost shelf. Consequently, thevial containers are securely retained within the corresponding containerreceptacles. The lid element and the plurality of shelves may defineclearance gaps between themselves of 0.1 inch or less, for example. Inembodiments with at least four shelves pivotally coupled to the mountingbar, the bottom wall of the top three shelves will act as lid elementsfor the shelves located directly below, at least when the shelves arerotated so as to be aligned with one another in contact with the stopbar.

The storage rack is therefore easily manipulated and vial containerstherein are easily retrieved, so that other product samples on thestorage rack can be returned to a cryogenic environment quickly to avoidthermal-inducted degradation of samples. Moreover, such actions with thestorage rack are intuitive for even those users without significantexperience using the storage rack.

In another embodiment of the present invention, a storage system isprovided for retaining products in a cryogenic environment. The storagesystem includes an outer sleeve element that is sized to be received ina cryogenic chamber, such as a liquid nitrogen-cooled storage tank. Thesystem also includes a storage rack that is configured to hold theproducts and also configured to be inserted into the outer sleeveelement during placement in the cryogenic chamber. The storage rack issimilar to the one described above, such as by including a framework, ahandle, and a plurality of shelves that are pivotally coupled to amounting bar and individually rotatable to a plurality of differentpositions relative to a stop bar.

In some embodiments, the storage system further includes a plurality ofcylindrical vial containers that each hold at least one of the products.The side wall of each of the plurality of shelves may define a generallycylindrical shape to allow the container receptacle defined therein toreceive one of the cylindrical vial containers. Each vial containerincludes a main body with a bottom end and a sidewall collectivelydefining an enclosure for receiving a vial or product, and a lid thatremovably engages the main body at a threaded engagement with thesidewall. Therefore, access to the vial or product is made easy by thethreaded connection between these elements. The storage rack with anyother products or samples can then be returned to the outer sleeveelement and the cryogenic container for future access and use, but itwill be understood that the plurality of shelves must typically bealigned with one another before the storage rack will fit into the rackreceptacle defined within the outer sleeve element. The storage systemalso includes a cryogenic storage container that holds a storage spacetherein at a desired temperature within a range of about −190° C. toabout −120° C.

In a further embodiment of the invention, a method of storing andretrieving products to be maintained at a desired temperature isprovided. The method includes placing a storage system within a storagespace of a cryogenic storage container that is held at the desiredtemperature. The storage system includes an outer sleeve element and astorage rack configured to hold the products and inserted into the outersleeve element. The storage rack is similar to the one described above,e.g., it includes a framework with an elongate mounting bar and a stopbar, a handle, and a plurality of shelves pivotally coupled to themounting bar. The method also includes removing the storage rack fromthe outer sleeve element and from the cryogenic storage container byengaging the gripping portion of the handle, which extends between thestop bar and the mounting bar. One shelf is then rotated away fromengagement with the stop bar to put the one shelf out of alignment froma remainder of the plurality of shelves. This rotation of the one shelfprovides access to one of the products that is stored at the one shelf.The retrieval of products is made quick and easy by this configurationof the storage system and storage rack, as a user can grab andmanipulate the storage rack with one hand on the handle, while usinganother hand to move the one shelf and a product on the one shelf. Assuch, thermal-induced degradation of other samples on the storage rackcan be more readily avoided when performing the method of the inventiondescribed herein.

These and other objects and advantages of the invention will become morereadily apparent during the following detailed description taken inconjunction with the drawings herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention and,together with a general description of the invention given above, andthe detailed description given below, serve to explain the invention.

FIG. 1 is a top perspective view of a storage system including aconventional storage rack and a storage sleeve configured to positionthe storage rack within a cryogenic storage container, the storage rackbeing separated from the storage sleeve to reveal additional features.

FIG. 2 is a top perspective view of a storage system including a storagerack and a storage sleeve configured to position the storage rack withina cryogenic storage container, in accordance with one embodiment of theinvention, the storage rack being shown to be separated from the storagesleeve with all shelves aligned against a stop bar.

FIG. 3 is a top perspective view of the storage rack of FIG. 2, but withone of the shelves rotated to an accessible position such that a roundproduct container (shown lifted out of the shelf) may be retrieved fromthe storage rack.

FIG. 4 is a partially exploded top perspective view of the shelf andround product container of FIG. 3, showing additional details of theround product container as well as a vial packing located within theround product container.

FIG. 5 is a top view of the storage rack of FIG. 2, with all shelvesbeing aligned such that the storage rack can be inserted back into thestorage sleeve, which is shown in phantom for reference.

FIG. 6 is a side view of the storage rack of FIG. 2.

FIG. 7 is a partially cross-sectioned perspective view of the storagerack and storage sleeve of FIG. 2 positioned within a cryogenic storagetank.

DETAILED DESCRIPTION

With reference to the Figures, and more specifically to FIGS. 2 through7, an exemplary storage system 10 including a storage rack 12 isillustrated, according to one embodiment of the invention. The storagesystem 10 is configured to be received within a cryogenic storagecontainer such that products or samples stored on the storage rack 12are maintained at a desired temperature, such as at a cryogenictemperature range of about −190° C. to about −120° C. The storage rack12 is designed to make manipulation and movement of the storage rack 12,shelves and containers on the storage rack 12 quick and easy, even forusers without significant experience working with the storage rack 12.Accordingly, other product samples on the storage rack can be reliablyreturned to the cryogenic environment quickly to avoid thermal-inducteddegradation of samples. The storage rack 12 therefore improves uponprior storage rack designs by addressing several of the shortfalls ofsuch conventional designs, including the one described above in theBackground section of this application (storage rack 300).

As shown in FIG. 2, the storage system 10 of this embodiment includes anouter sleeve element 14 and the storage rack 12, which is configured tobe inserted into the outer sleeve element 14 for storage in a cryogenicstorage container or other similar refrigerated space. The outer sleeveelement 14 is generally tube-shaped and includes a cylindrical sidewall16 extending between a closed bottom end 18 (may be a wall that is solidor perforated) and an open top end 20. The outer sleeve element 14typically further includes a handle rod 22 that is fixedly coupled tothe sidewall 16 proximate the open top end 20 and that projects upwardlyabove the open top end 20 so that the outer sleeve element 14 can bemoved and manipulated by a user. In an exemplary embodiment, the outersleeve element 14 is formed from a rigid metal material such asstainless steel (e.g., 304 SS or 316 SS), but it will be appreciatedthat other types of materials appropriate for use in cryogenictemperature environments may also be used.

The sidewall 16 and closed bottom end 18 of the outer sleeve element 14enclose a rack receptacle 24, which is a generally cylindrical interiorspace sized to receive the storage rack 12, at least when the storagerack 12 is in the configuration shown in FIG. 2. To this end, the rackreceptacle 24 may be sized only slightly larger than the storage rack 12to help maintain the aligned configuration of the storage rack 12 afterinsertion into the outer sleeve element 14. The outer sleeve element 14can then be moved with the storage rack 12 by a user to and from thecryogenic storage. It will be understood that the particular shape andsize of the outer sleeve element 14 may be modified in other embodimentsto match corresponding revisions that may be made in the shape or designof the storage rack 12, without departing from the scope of theinvention.

The storage rack 12 of this embodiment is shown in further detail inFIGS. 2 and 3. In this regard, the storage rack 12 includes a framework28 defined by an elongate mounting bar 30 and an elongate stop bar 32that are coupled to one another so as to be in generally parallelrelationship. For example, a handle 34 is provided on the storage rack12 so as to extend between top ends of the mounting bar 30 and the stopbar 32. The handle 34 therefore couples the mounting bar 30 and stop bar32 together, while providing additional functionality to the storagerack 12 as described in further detail below. Moreover, the framework 28typically further includes a support foot 36 that is shown connected toand extending from a bottom end of the mounting bar 30 in FIGS. 2 and 3.The support foot 36 may also be connected to and extending from a bottomend of the stop bar 32 in some embodiments, which will provide anadditional coupling of these elements together. Additional connectingelements (not shown in this embodiment) may extend between the mountingbar 30 and the stop bar 32 along their length to maintain these elementsof the framework 28 in the desirable parallel configuration, in someembodiments. Regardless of how the framework 28 is connected together,the mounting bar 30 and the stop bar 32 provide mounting and alignmentfunctionalities for a plurality of shelves 38 included in the storagerack 12.

The framework 28 in this embodiment is formed from elongated cylindricalrod stock, which may be formed from stainless steel or another similarrigid material configured to provide structural strength and withstandcryogenic environments. The rod stock may be solid in cross section orhollow, depending on the preferences of the end user. The support foot36 may be formed integrally as a unitary piece with the mounting bar 30and/or stop bar 32, in which case the support foot 36 is also formedfrom the same rod stock. However, the support foot 36 may be formedseparately and fixedly secured into connection with the mounting bar 30in other embodiments. Although the shape and profile of the support foot36 is not visible in FIGS. 2 and 3, it will be understood that thesupport foot 36 can define a hollow enclosed triangular shape orrectangular shape extending along a plane (which is visible in FIG. 6,for example). Furthermore, the support foot 36 can define any shape andsize in other embodiments, so long as the support foot 36 providessufficient support for holding the storage rack 12 in an uprightposition on a surface as shown in the different configurations at FIGS.2 and 3. To this end, in most embodiments, the support foot 36 willextend in some manner across a majority of the footprint of the storagerack 12, defined by the plurality of shelves 38 when in the alignedconfiguration of FIG. 2, to provide the necessary support for holdingthe storage rack 12 in the upright position.

Turning with reference to the plurality of shelves 38, the storage rack12 of the illustrated embodiment includes four shelves 38 a, 38 b, 38 c,38 d (collectively referred to as 38) positioned one immediately abovethe other. It will be understood that more or fewer shelves, such as upto 12 shelves in some embodiments, may be provided in accordance withthis invention. Each of the shelves 38 is defined by a bottom wall 40extending generally horizontally in the upright position shown in FIGS.2 and 3, and a side wall 42 extending generally vertically and upwardlyfrom the bottom wall 40. The side wall 42 is generally cylindrical inthe illustrated embodiment, but it will be appreciated that a pluralityof sidewalls may extend upwardly from the bottom wall 40 in otherembodiments of the storage rack 12 consistent with the scope of thepresent invention. Regardless of the particular configuration and shapeof the bottom wall 40 and side wall 42, these components collectivelydefine a container receptacle 44 that is sized to receive a vialcontainer or some other product holding container. Therefore, on theillustrated embodiment of the storage rack 12, the plurality of shelves38 collectively provide four container receptacles 44 that are eachsized to receive a vial container, which enables the storage rack 12 tohold a plurality of product samples for cryogenic storage. In somefields, a partial portion of the vial containers will hold reservematerials, while the other partial portion of the vial containers willhold samples that are to be used for treatment or testing, in theexample of the samples being biological cells or the like.

Each of the shelves 38 is pivotally coupled to the mounting bar 30 ofthe framework 28. For example, in the illustrated embodiment the sidewall 42 of each shelf 38 includes one or more hinge sleeves 46 that areconnected to an outside surface of the side wall 42. The hinge sleeves46 are provided in this embodiment as hollow members that are sized toreceive the mounting bar 30 in a relatively close fit. To this end, thehinge sleeves 46 may define a hollow opening that is about 0.030 inchesto 0.100 inches larger than the cross-sectional size of the rod stockdefining the mounting bar 30, which provides a close fit but sufficientclearance to enable the pivotal movement between these elements. Thehinge sleeves 46 of adjacent shelves 38 can abut one another (or definesufficiently small gaps therebetween) in some embodiments to preventsignificant vertical movement of the shelves 38 along the elongatelength of the framework 28. Nevertheless, no further bearing or mountingelements are required in the illustrated embodiment to hold the shelves38 in position, e.g., with one above the other as shown. Some of thehinge sleeves 46 are shown with a generally square cross section, whileothers of the hinge sleeves 46 are shown with a generally cylindricalcross section. It will be understood that so long as the clearance gapprovided between the hinge sleeves 46 and the mounting bar 30 issufficient to enable the pivotal movement of the shelves 38, theparticular shape and configuration of the hinge sleeves 46 can befurther modified in other embodiments.

As with the other elements described above, the shelves 38 and thecomponents defining the same are typically formed from stainless steel,such as 304 SS or 316 SS, or a similar structural, rigid material. Whenmost of the elements of the storage rack 12 and storage system 10 areprovided from a stainless steel material, the storage solution has highdurability and reliability for many storage cycles. Furthermore, themanufacturing and assembly of the elements of the storage system 10 isstraightforward, as it may be performed by known metal shaping andcoupling techniques (e.g., welding and the like). The specific materialschosen for the shelves 38 and the other elements of the storage system10 may be modified without undermining the various benefits andfunctionalities of this design.

As shown in FIGS. 2 and 3, the side wall 42 of each of the shelves 38extends to a top end 50 that is positioned at an opposite vertical endfrom the connection of the side wall 42 to the bottom wall 40. The topend 50 defines an opening into the container receptacle 44 through whichthe vial containers or other elements stored on the shelves 38 can beretrieved and manipulated. In the exemplary embodiment shown, the sidewall 42 further includes at least one cutout 52 projecting downwardlyfrom the top end 50 and towards the bottom wall 40. More specifically,the side wall 42 has a pair of opposing cutouts 52 that are formedgenerally on opposite sides of the shelf 38. The cutouts 52 are sized tobe large enough to receive at least one or two fingers of a user, andthey may extend a partial portion (e.g., about 25%-35%) of thelongitudinal length of the shelf 38 defined between the top end 50 andthe bottom wall 40.

As will be readily understood from FIG. 3, the cutouts 52 provide aconvenient gripping area for a user to grab onto the top of a vialcontainer 60 that is to be pulled out of the corresponding containerreceptacle 44 via the top end 50. While opposing cutouts 52 are shownand allow for a clamp like grip to be formed by a user with only onehand on the vial container 60, it will be understood that a differentnumber of cutouts 52 may be provided on each shelf 38 in otherembodiments consistent with the scope of the invention. Moreover, whilethe cutouts 52 are shown with generally straight edges 54 and arectangular shape in this embodiment, the particular edge profile of thecutouts 52 may be modified depending on the preferences of the end userof the storage rack 12. When one or more of the shelves 38 c is rotatedout of alignment with the other shelves 38 a, 38 b, 38 d on the storagerack 12, the cutouts 52 and top end 50 provide open and easy access forremoval and/or replacement of a vial container 60 to and from thestorage rack 12.

As initially described above, each of the shelves 38 is pivotallycoupled to the mounting bar 30 so that the shelves 38 are configured tobe individually and independently rotated relative to the mounting bar30 towards and away from contact with the stop bar 32. In this regard,the stop bar 32 provides a limit on the rotation of any shelf 38 in bothdirections when pivoting around the periphery of the mounting bar 30,but each shelf 38 is still capable of moving through a swing angle ofabout 270 degrees or more between end conditions contacting the oppositesides of the stop bar 32. That freedom of rotational movement allows forthe plurality of shelves 38 to be repositioned relative to one anotherin a multitude of different configurations and positions.

One such position is shown in FIG. 2, with all of the shelves 38 a, 38b, 38 c, 38 d rotated into contact with the stop bar 32 and intoalignment with one another. The FIG. 2 position is designed for storagewithin the outer sleeve element 14 and a cryogenic storage container, asthe effective footprint of the storage rack 12 is minimized to just thesize of one of the shelves 38 (and the mounting bar 30 and stop bar 32of the framework 28 of course). Another such position is shown in FIG.3, in which one of the shelves 38 c is rotated away (shown by arrow 56)from the remainder and away from the stop bar 32 to move that shelf 38 ccompletely out of alignment with the other shelves 38 a, 38 b, 38 d. Asshown by the partially exploded view in FIG. 3, this configuration ofthe shelves 38 on the storage rack 12 enables access for removal and/orreplacement of the vial container 60 to and from the containerreceptacle 44 defined within the one shelf 38 c. To this end, the opentop end 50 is revealed along with the cutouts 52 for allowing a user'shand to grasp the top of a vial container 60 within the containerreceptacle 44. In addition, with the bottom wall 40 of the one shelf 38c rotated away from the top end 50 of the shelf 38 d immediately belowthe one shelf 38 c, the open top end 50 and the cutouts 52 of thatadjacent shelf 38 d are also revealed for access by a user, if desired.

The shelves 38 can therefore be repositioned to provide access to anyone or all of the container receptacles 44 in quick and easy manner, asa user can rotate a shelf 38 with one hand and then use the same hand toretrieve the vial container 60 by lifting it out of the correspondingcontainer receptacle 44. The shelves 38 of the storage rack 12 are shownin two exemplary configurations and positions, one for storage, and oneproviding access into some of the container receptacles 44, but it willbe appreciated that many other configurations and shelf positions arealso possible when using the storage rack 12 of this invention.

The rotatable configuration of the plurality of shelves 38 also providesanother benefit that is visible when comparing the states of FIGS. 2 and3. To this end, the bottom wall 40 of each of the shelves 38 a, 38 b, 38c above the lowermost one 38 d effectively serves as a lid element forthe shelf 38 b, 38 c, 38 d (respectively) located directly below it insequence, particularly when the shelves 38 are aligned with one anotherin the storage position as shown in FIG. 2. The shelves 38 are mountedon the mounting bar 30 so that the clearance gaps, if any, between twoadjacent shelves 38 in the series are about 0.1 inch or less. Theclearance gap is substantially invisible in the side view of FIG. 6, forexample. Therefore, no separate lids or wall elements need to be mountedon the framework 28 to cover and close the container receptacles 44 foreach of the shelves 38 b, 38 c, 38 d except for the uppermost one 38 a,and this simplifies and reduces cost of manufacturing the storage rack12 while maintaining reliable retention of vial containers 60 in thesubstantially closed container receptacles 44 (when in the alignedstorage position). It will be appreciated that the storage rack 12 inother embodiments in accordance with the invention may further includeone or more additional lid elements mounted to the framework 28 betweenthe shelves 38, but it is preferable to use the bottom walls 40 for sucha function as shown in the drawings.

The uppermost of the plurality of shelves 38 a on the storage rack 12does not have an adjacent shelf with a bottom wall that can serve as alid element in the storage position. As a result, in the exemplaryembodiment of the storage rack shown in the Figures, a separate lidelement 58 is fixedly coupled to one or both of the mounting bar 30 andthe stop bar 32 at a position adjacent the top end 50 of the uppermostone of the shelves 38 a. The lid element 58 is configured as a planarround plate in the embodiment shown in FIGS. 2 and 3, although theparticular shape of the lid element 58 could be modified in otherembodiments so as to be consistent with any variations in thecross-section of the shelves 38. Consequently, the lid element 58 isconfigured to be similar to the bottom wall 40 of the other shelves 38,just without being rotatable relative to the mounting bar 30 and withoutthe side wall 42 extending further upwardly from the lid element 58. Itwill be appreciated that the lid element 58 could be omitted in someembodiments in which closure of the container receptacles 44 is notrequired, as the shelves 38 are adapted to reliably retain the vialcontainers 60, regardless of whether a lid element is provided.

The vial container 60 developed for use with the storage system 10 ofthis invention is shown in further detail in FIGS. 3 and 4. In thisregard, the vial container 60 is a cylindrical vial container in thisembodiment so that the vial container 60 fits within the generallycylindrical space defined by the container receptacles 44 of theplurality of shelves 38. Each of the vial containers 60 is sized to holdat least one sample or product, which may include, but is not limitedto: biological samples such as tissue samples or stem cells, allogeneicdrug products, and autologous drug products, for example. As these typesof products and samples typically require continuous storage atcryogenic temperatures of −120° C. or less, the ease and speed withwhich a user can retrieve one of the samples and then return any otherson the shelf 38 or storage rack 12 back to cryogenic storage isimportant in this field, so as to avoid temperature-induced degradationof the other samples on the storage rack 12. The vial container 60 hasbeen designed with those needs being considered.

For example, by making the vial container 60 generally cylindrical, themechanism for opening the vial container 60 can be redesigned to use arotatable threaded engagement rather than flaps and panels (“box ears”)that must be bent open and closed as with conventional plastic orcardboard box-shaped designs. To this end, each of the vial containers60 shown in the storage system 10 of this embodiment includes a mainbody 62 defined by a bottom end 64 and a sidewall 66 that collectivelyenclose an enclosure 68 configured to receive a vial 70 containing thesample or product. The sidewall 66 on the main body 62 includes threads72 which may be engaged with corresponding threads 72 formed on a lid 74that removably engages with the main body 62 to open and close theenclosure 68. The sidewall 66 on the main body 62 may be recessed to beslightly smaller in cross section near a top end so that the lid 74(specifically a sidewall thereof) can slide down over this portion ofthe sidewall 66, which allows the lid 74 and the main body 62 to providea generally uniform profile when fully assembled. Regardless, the lid 74can be removed and replaced relative to the main body 62 of the vialcontainer 60 in a quick and intuitive manner, even for users not highlyexperienced with this particular storage system 10 design.

The vial container 60 may be formed from a plastic material or anothersimilar material. The vial 70 containing the sample or product is oftensignificantly smaller in size than the enclosure 68 defined within vialcontainer 60, and as such, the vial 70 may optionally be furthercontained within a holder 76 that is sized to span the gap between thevial 70 and the sidewall 66 defining the enclosure 68. The holder 76 isshown as a cardboard or plastic box-shaped element with an outer profilesized to fit just within the enclosure 68, and an inner chamber orsleeve sized to receive the vial 70. The holder 76 maintains theposition of the vial 70 within the enclosure 68 so as to avoidundesirable jostling or impacts of the vial 70 moving around inside theshelves 38 during movement and manipulation of the shelves 38 and/or ofthe storage rack 12 in its entirety. The holder 76 may be designed tohold more than one vial 70, or different shapes and sizes of vials, inother embodiments of the invention.

Turning now with reference to FIGS. 5 and 6, the storage rack 12 isshown from multiple sides while in the aligned position of the shelves38 to illustrate further features. For example, the specific positioningand profile of the handle 34 on the storage rack 12 is shown in furtherdetail. The handle 34 of this embodiment is connected to and extendsbetween the mounting bar 30 and stop bar 32 as described above. Thehandle 34 may be formed integrally as a unitary piece from a similarstainless steel rod stock as the mounting bar 30 and the stop bar 32,for example. The handle 34 is bent and profiled in such a manner toprovide an enlarged gripping area 80 for a user to hold when moving andmanipulating the storage rack 12. This enlarged gripping area 80 isconveniently located so that movements of the storage rack 12 as a wholeare made easy relative to the outer sleeve element 14 and/or a cryogenicstorage container.

More particularly, the handle 34 as shown in FIGS. 5 and 6 projects bothhorizontally and upwardly from the top ends of the stop bar 32 and themounting bar 30. The handle 34 includes generally straight portions 82extending generally horizontally and perpendicular to the top ends ofthe stop bar 32 and the mounting bar 30, in a direction over the shelves38 when the shelves 38 are in the aligned storage position. The handle34 also includes a generally arcuate portion 84 that extends in avertical plane from the ends of the generally straight portions 82opposite the top ends of the mounting bar 30 and the stop bar 32. Thegenerally arcuate portion 84 follows a semi-circular path between theconnections with the straight portions 82 of the handle 34. Thus, thearcuate portion 84 of the handle 34 extends over the shelves 38 atroughly the center of the shelves 38, as most visible in FIG. 5, and thearcuate portion 84 defines the curved configuration to provide thegripping area 80. As compared to straight rod-like handles or the smallclip handle shown in the prior art design discussed with reference toFIG. 1 above, the enlarged gripping area 80 on the handle 34 enableseasy movement and manipulation of the entire storage rack 12 with justone hand of a user. Accordingly, a user has another hand free to conductthe manipulation of the shelves 38 and access of the vial containers 60.The specific curvature and profile of the handle 34 may be modified inother embodiments, as long as the enlarged gripping area 80 is stillprovided to make the storage rack 12 easier to work with and manipulate,to enable quick retrieval of products or samples and thereby avoidtemperature-induced degradations of other products or samples on thestorage rack 12.

By providing the storage system 10 and storage rack 12 with the featuresdescribed herein, users of all experience levels can quickly and easilyretrieve and return products and samples to and from a cryogenic storageenvironment. The enlarged gripping area 80 of the handle 34 renders thestorage rack 12 easy to grasp and manipulate relative to the outersleeve element 14, for example. The rotatable plurality of shelves 38then makes it simple for the user to move a shelf 38 to an accessibleposition out of alignment with the other shelves 38, such that a vialcontainer 60 can be moved into or out of the container receptacle 44 atthe shelf 38. The vial container 60 itself is also configured to be easyto use, with the threaded engagement of the lid 74 making it easy toopen the enclosure 68 and access the vial 70 containing the product orsample. These elements of the storage rack 12 are easy to access,disassemble, and re-assemble to limit the exposure time to ambienttemperatures for all other products and samples stored on the storagerack 12. Consequently, the storage system 10 and storage rack 12 iseasier for all users of all experience levels to work with, while alsoreducing the time needed for accessing products and samples to avoidthermal degradation issues.

One typical environment in which the storage rack 12 is stored is acryogenic storage tank 90 configured for shipping and transport betweenlocations, as shown in FIG. 7. To this end, the storage system 10 insome embodiments includes the cryogenic storage tank 90, or some othersimilar cooling enclosure configured to hold elements at a low desiredtemperature such as in the range of −195° C. to about −120° C. Thecryogenic storage tank 90 is a known type of enclosure which typicallycontains liquid nitrogen (LN2) as a coolant for holding the temperaturewithin an interior 92 of the tank 90 at the low cryogenic temperature.The tank 90 also includes a top opening 94 that can be closed by a capmember 96 that threadably engages with the tank 90. The cap member 96and the walls of the tank 90 are insulated with foam material or similarto help maintain the cryogenic temperatures within the interior 92. Thetank 90 shown in FIG. 7 is sized so as to receive a single storage rack12, placed within the outer sleeve element 14 as described previously.As can be seen in FIG. 7, the handle 34 is conveniently positioned suchthat when the cap member 96 is removed, the handle 34 is located foreasy access to allow movement of the storage rack 12 upwardly and out ofthe cryogenic storage tank 90. It will be understood that the specificcryogenic storage container used with the storage system 10 can bemodified to other known designs, some of which may contain multiplestorage racks 12, without departing from the scope of this invention.

While the present invention has been illustrated by a description of anexemplary embodiment and while this embodiment has been described inconsiderable detail, it is not the intention of the applicant torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. The invention in its broader aspects istherefore not limited to the specific details, representative apparatusand method, and illustrative example shown and described. Accordingly,departures may be made from such details without departing from thescope of Applicant's general inventive concept.

What is claimed is:
 1. A method of storing and retrieving products to bemaintained at a desired temperature, the method comprising: assembling astorage system by inserting a storage rack configured to hold theproducts into an outer sleeve element, with the storage rack comprising:a framework including an elongate mounting bar and an elongate stop barcoupled to one another and extending generally parallel to one another;a handle coupled to at least one of the stop bar and the mounting bar,the handle including an enlarged gripping portion; and a plurality ofshelves pivotally coupled to the mounting bar so as to be individuallyand independently rotatable relative to an axis through the mounting bartowards and away from contact with the stop bar; keeping the storagesystem within a storage space of a cryogenic storage container that isheld at the desired temperature; removing the storage rack from theouter sleeve element and from the cryogenic storage container byengaging the gripping portion of the handle; and rotating one selectedshelf of the plurality of shelves away from engagement with the stop barto place the selected shelf out of alignment from a remainder of theplurality of shelves, to thereby provide access to one of the productsstored at the selected shelf.
 2. The method of claim 1, wherein each ofthe plurality of shelves includes a bottom wall and a side wallcollectively defining a generally cylindrical container receptacle, andthe method further comprises: removing a cylindrical vial container fromthe container receptacle of the selected shelf rotated out of alignmentfrom the remainder of the plurality of shelves; and disengaging a lid ofthe cylindrical vial container from a main body of the cylindrical vialcontainer to access a vial held within the cylindrical vial container.3. The method of claim 2, wherein the lid and the main body of thecylindrical vial container are threadably engaged by threads on the lidand on the main body, and the step of disengaging the lid of thecylindrical vial container from the main body further comprises:disengaging the threaded engagement of the threads on the lid from thethreads on the main body by rotating the lid relative to the main body.4. The method of claim 2, wherein the lid of the cylindrical vialcontainer includes a sidewall, the main body of the cylindrical vialcontainer includes a sidewall that includes a recessed portion near atop end thereof such that the lid can slide down over the recessedportion when engaging the main body, and the step of disengaging the lidof the cylindrical vial container from the main body further comprises:sliding the lid away from the recessed portion of the main body toremove an engagement between the sidewall of the lid and the sidewall ofthe main body.
 5. The method of claim 2, wherein the side wall of eachof the plurality of shelves includes a pair of opposing cutouts formedon opposite sides of the side wall at a top end thereof, and the step ofremoving the cylindrical vial container from the container receptacle ofthe selected shelf further comprises: grasping the lid of thecylindrical vial container at the pair of opposing cutouts; and liftingthe cylindrical vial container upwardly out of the container receptacle.6. The method of claim 1, wherein each of the plurality of shelves ispivotal relative to the mounting bar between end positions defined byshelf contact with opposite sides of the stop bar, and the step ofrotating one selected shelf of the plurality of shelves away fromengagement with the stop bar further comprises: rotating the selectedshelf away from contact with one side of the stop bar to any of aplurality of different positions defined between the end positions, tothereby bring the selected shelf out of alignment with the remainder ofthe plurality of shelves.
 7. The method of claim 6, wherein the step ofrotating one selected shelf of the plurality of shelves away fromengagement with the stop bar further comprises: rotating the selectedshelf through an entirety of a swing angle defined between the endpositions until the selected shelf is in contact with the opposite sideof the stop bar at another of the end positions, wherein the selectedshelf is out of alignment with the remainder of the plurality of shelvesin this configuration.
 8. The method of claim 7, wherein the swing angleis about 270 degrees.
 9. The method of claim 6, further comprising:rotating multiple shelves in the plurality of shelves to differentpositions defined between the end positions to reposition the multipleshelves in different configurations and positions relative to oneanother.
 10. The method of claim 1, wherein the step of keeping thestorage system within the storage space of the cryogenic storagecontainer further comprises: maintaining a temperature within thestorage space of the cryogenic storage container within a range of about−195° C. to about −120° C., wherein the desired temperature is withinthis range.
 11. The method of claim 1, wherein the outer sleeve elementis sized to receive the storage rack only when all of the plurality ofshelves are aligned with one another, and the step of assembling thestorage system further comprises: aligning the plurality of shelves withone another by rotating each of the plurality of shelves into contactwith one side of the stop bar.
 12. The method of claim 11, wherein thestorage rack also includes a lid element fixedly coupled to one or bothof the mounting bar and the stop bar, and the step of aligning theplurality of shelves with one another further comprises: rotating anuppermost one of the plurality of shelves underneath the lid element tocover products stored in the uppermost one of the plurality of shelves;and rotating a remainder of the plurality of shelves underneath theuppermost one of the plurality of shelves, such that products stored ineach of the remainder of the plurality of shelves are covered by theshelf immediately above each shelf.
 13. The method of claim 1, whereinthe handle extends between and is coupled to each of the stop bar andthe mounting bar such that the enlarged gripping portion of the handleprojects over a portion of the plurality of shelves, and the step ofremoving the storage rack from the outer sleeve element and from thecryogenic storage container further comprises: lifting the handle at theenlarged gripping portion in an upward direction to remove the storagerack from the outer sleeve element and from the cryogenic storagecontainer, to thereby provide clearance for the plurality of shelves topivot about the mounting bar.
 14. The method of claim 13, wherein theenlarged gripping portion defines a curved configuration and isconfigured to enable an operator to lift and hold the storage rack withone hand at the enlarged gripping portion while another hand is free torotate and manipulate one or more of the plurality of shelves.
 15. Themethod of claim 1, wherein the plurality of shelves includes at leastfour shelves, and the step of removing the storage rack from the outersleeve element and from the cryogenic storage container furthercomprises: lifting the storage rack upwardly out of the outer sleeveelement such that all of the at least four shelves are positionedoutside the cryogenic storage container and can be manipulated toprovide access to the products.